PMA P040027S009
- Device
- GORE VIATORR TIPS ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S009
- Product code
- MIR
- Decision date
- 2008-04-18
- Classification
- Shunt, Portosystemic, Endoprosthesis
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- APPROVAL FOR CHANGES TO THE ETHYLENE OXIDE STERILIZATION CYCLE.
Current openFDA PMA Record#
- Device
- GORE VIATORR TIPS ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040027
- Supplement
- S009
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2008-04-18
- Decision code
- APPR
- Date received
- 2007-12-07
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE ETHYLENE OXIDE STERILIZATION CYCLE.